Quality Engineer II - CAPA & Validation (Med Device)

Medtronic; Mystic (CT); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Dental and vision insurance

401(k) plan + employer match

Tuition assistance/reimbursement

Paid time off

Job summary

Medtronic seeks a Quality Engineer II to support quality system activities in a regulated medical device setting at the Mystic, Connecticut site. The role emphasizes nonconformance management, CAPA, calibration, and validation across IQ/OQ/PQ processes with cross‑functional collaboration to sustain quality and drive continuous improvement.

Onsite work five days a week, no travel required. Requires a Baccalaureate degree with 2+ years of experience or a Master’s degree with minimal experience.

Qualifications

• Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master’s degree with a minimum of 0 years relevant experience.
• Experience supporting quality system processes within a regulated manufacturing environment.
• Experience with nonconformance investigations, root cause analysis, and corrective action implementation.
• Working knowledge of quality documentation requirements and regulatory compliance standards.
• Ability to manage multiple projects and priorities while maintaining accurate and compliant documentation.

Responsibilities

• Support nonconformance investigations and partner with cross-functional teams to identify root causes and implement corrective actions.
• Facilitate CAPA activities, including documentation, effectiveness verification, and closure.
• Maintain compliance of calibration programs and support calibration‑related quality activities.
• Execute and support process and equipment validation activities, including IQ, OQ, PQ, and related validation documentation.
• Collaborate with manufacturing and engineering teams to establish, implement, and maintain product and process quality requirements.
• Develop, revise, and maintain quality documentation, procedures, and records to ensure compliance with quality system requirements.
• Analyze quality data and trends to identify improvement opportunities and support risk‑based decision‑making.
• Participate in internal audits, inspections, and regulatory readiness activities to ensure ongoing compliance.

Skills

CAPA

Nonconformance

Root cause analysis

Regulatory compliance

Education

Baccalaureate degree

Master’s degree

Tools

SAP

TrackWise

Job description

Medtronic seeks a Quality Engineer II to support quality system activities in a regulated medical device setting at the Mystic, Connecticut site. The role emphasizes nonconformance management, CAPA, calibration, and validation across IQ/OQ/PQ processes with cross‑functional collaboration to sustain quality and drive continuous improvement.

Onsite work five days a week, no travel required. Requires a Baccalaureate degree with 2+ years of experience or a Master’s degree with minimal experience.